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A Phase II Study of the Combination of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With CD20 Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT)

Trial Information

A Phase II Study of the Combination of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With CD20 Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT)

OBJECTIVES:

- Determine the safety and toxicity of cyclophosphamide, rituximab, and prednisone or
methylprednisolone in patients with CD20-positive and Epstein-Barr virus-positive
post-transplant lymphoproliferative disease (PTLD) after solid organ transplantation.

- Determine the 2-year event-free survival, defined as alive and in continuous complete
remission with a functioning original allograft, of patients treated with this regimen.

- Determine the response rate in patients treated with this regimen.

- Determine the PTLD gene expression profile by microarray analysis and fluorescent in
situ hybridization in patients treated with this regimen.

- Determine the accrual rate of patients to this study.

OUTLINE: This is a multicenter study.

Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or
methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also
receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days
for up to 6 courses in the absence of disease progression, a new primary or secondary
malignancy, or unrelated disease.

After finishing study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 60 patients (50 with non-fulminant post-transplant
lymphoproliferative disease [PTLD] and 10 fulminant PTLD) will be accrued for this study
within 2.5-3 years.

Type of Study:

Study Design:

Outcome Measure:

Event-free survival at 2 years

Outcome Description:

Estimated by Kaplan-Meier method. The correlation between outcome (EFS or OS) and covariates such as EBV viral load, EBV-CTL, subsets of PBL, dendritic cells in peripheral blood, and peripheral blood levels of Rituximab will be evaluated using the proportional hazards model. The correlation between gene expression and survival will also be evaluated using the proportional hazards model

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Thomas G. Gross, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Nationwide Children's Hospital

Authority:

United States: Federal Government

Study ID:

ANHL0221

NCT ID:

NCT00066469

Start Date:

April 2004

Completion Date:

Related Keywords:

Lymphoproliferative Disorder

post-transplant lymphoproliferative disorder

Lymphoproliferative Disorders

Name

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

Mayo Clinic Cancer Center

Rochester, Minnesota 55905

University of Chicago Cancer Research Center

Chicago, Illinois 60637

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan 48201

Medical City Dallas Hospital

Dallas, Texas 75230

University of Texas Health Science Center at San Antonio

San Antonio, Texas 78284-7811

CCOP - Kalamazoo

Kalamazoo, Michigan 49007-3731

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee 37232-6838

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin 54449

New York Medical College

Valhalla, New York 10595

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri 65203

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina 27599-7570

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio 44195

Children's Mercy Hospital

Kansas City, Missouri 64108

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15213

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington 98105

Nemours Children's Clinic

Jacksonville, Florida 32207

All Children's Hospital

St. Petersburg, Florida 33701

Children's Memorial Hospital - Chicago

Chicago, Illinois 60614

Driscoll Children's Hospital

Corpus Christi, Texas 78466

Inova Fairfax Hospital

Falls Church, Virginia 22042-3300

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont 05401

Phoenix Children's Hospital

Phoenix, Arizona 85016-7710

Southern California Permanente Medical Group

Downey, California 90242

Kosair Children's Hospital

Louisville, Kentucky 40202-3830

Sunrise Hospital and Medical Center

Las Vegas, Nevada 89109-2306

East Tennessee Children's Hospital

Knoxville, Tennessee 37901

Children's Hospital of the King's Daughters

Norfolk, Virginia 23507

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

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